A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

• Drug: PF-05082566
  Starting dose of 0.45 mg/kg q3wks IV, dose escalation
• Drug: MK-3475
  2 mg/kg q3wks, IV
  Other Name: pembrolizumab

Inclusion Criteria:

• Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
• Measurable disease per RECIST v1.1.
• Adequate bone marrow, renal and liver functioning

Exclusion Criteria:

• CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.

• History of any of the following toxicities associated with a prior immunotherapy:

  • Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
  • Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy
• Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
• History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).